Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration in Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration for Postoperative Pain in Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419701
• Other study ID #: pain in knee arthroplasty
• Status: Completed
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: June 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves the patient satisfaction.

The aim of perioperative pain control is to minimize delays in recovery, postoperative delirium and pain-related stress responses that can lead to serious morbidity and poor outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have been evaluated, as poorly controlled acute postoperative pain can be associated with persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems to be closely associated with chronic post-TKA pain, with similar mechanisms underlying hyperalgesia or chronic pain.

Description:

Total knee arthroplasty (TKA), one of the most commonly performed operations in orthopaedic department, has been a successful intervention for patients with end-stage knee arthritis.

Rehabilitation after total knee arthroplasty (TKA) routinely starts immediately after surgery on the postoperative ward and therefore requires adequate analgesia. An ideal analgesic modality for post-TKA rehabilitation should permit adequate knee flexion with minimal pain without motor impairment, resulting in successful mobilization. Pain control plays an essential role in the overall postoperative period for the patients undergoing TKA.

Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves the patient satisfaction.

The aim of perioperative pain control is to minimize delays in recovery, postoperative delirium and pain-related stress responses that can lead to serious morbidity and poor outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have been evaluated, as poorly controlled acute postoperative pain can be associated with persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems to be closely associated with chronic post-TKA pain, with similar mechanisms underlying hyperalgesia or chronic pain.

Traditionally, the degree of knee flexion has been used as an outcome measure after TKA to evaluate functional recovery and the success of the type of analgesia used.

Several methods such as intravenous opioids, extraarticular and intraarticular injection, epidural analgesia and femoral or sciatic nerve blocks are currently used for postoperative pain management.

However, each method is reported with potential side effects, for example, opioid drugs caused vomiting, nausea, constipation, dizziness and urinary retention, epidural analgesia with urinary retention, respiratory depression and spinal headache, femoral or sciatic block with diminished muscle control and possible nerve damage.

Periarticular multimodal drug injection in TKA is a technique that patients received intraoperative drug injection in the periarticular fields such as posterior capsule, medial and lateral collateral ligaments, quadriceps mechanism and peripatellar tissue at the end of the surgery. Multimodal drugs mainly consist of local anaesthetics, non-steroidal anti-inflammatory drugs, opioids, epinephrine with or without corticosteroid.

Genicular nerve block (GNB) and ablation have been used for managing chronic pain from knee osteoarthritis with good success.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 15, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• unilateral knee arthroplasty surgery,

• aged more than 50 years of both genders.

• have american society of anesthesiologist physical status I-II and III.

Exclusion Criteria:

• Revision knee arthroplasty,

• previous surgery or trauma to knee,

• drug allergy, regular narcotic use,

• renal impairments

• hepatic impairments,

• neuromuscular diseases

• coagulopathy disorders.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• periarticular infiltration
The cocktail will be injected at the following 7 anatomical zones as follows: Zone 1: medial retinaculum Zone 2: medial collateral ligament and medial meniscus capsular attachment Zone 3: posterior capsule Zone 4: lateral collateral ligament and lateral meniscus capsular attachment Zone 5: lateral retinaculum Zone 6: patellar tendon and fat pad Zone 7: cut ends of quadriceps muscle and tendon Injection at zones 2, 3, and 4 will be administered after making the tibial and femoral cuts and ligament balancing. At zones 1, 5, 6, and 7, the injection will be administered after implant placement.
• genicular nerve block
The genicular arteries will be identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound. genicular nerve block target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve.After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view.

Locations

Country	Name	City	State
Egypt	Tarek Abdel Hay	Tanta	El Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee range of motion	The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees	postoperative first day
Other	Knee range of motion	The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees	postoperative second day
Other	Knee range of motion	The knee primarily only moves in one plane of movement, flexion and extension. A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees	postoperative third day
Primary	total doses of postoperative opioid consumption	total doses of postoperative rescue morphine consumption	postoperative first day
Secondary	Time of the first dose of rescue analgesia	Time of the first dose of rescue morphine analgesia at dose of 3 mg	postoperative first day